RecruitingNCT07565727
Cardiometabolic Disease and Substrate Metabolism
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Sponsor
University of Tennessee Graduate School of Medicine
Enrollment
50 participants
Start Date
Dec 10, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria7
- Age 18-45
- Any pre-pregnancy BMI
- At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines
- Willingness to adhere to aspirin therapy
- Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
- Gestational age at enrollment <18 weeks
- Ability to speak, read, and communicate via English
Exclusion Criteria14
- Type 2 Diabetes Mellitus
- Type 1 Diabetes Mellitus
- Current gestational diabetes mellitus
- Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
- Thrombophilia
- Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
- Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
- Current or recent use of steroids
- Current use of prophylactic or therapeutic anticoagulation
- Medical contraindication to aspirin therapy
- Molar pregnancy
- Renal disease
- Inability or unwillingness to give informed consent
- Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07565727
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